PRECLINICAL ASSESSMENT OF A STEM CELL THERAPEUTIC MEDICINAL PRODUCT FOR CLINICAL APPLICATION IN COLORECTAL CANCER

The main purpose of the Andalusian Initiative for Advanced Therapies (AIAT) is the translation of basic research in this specific field to the clinic. One of the most critical aspects is the completion of preclinical studies. In this regard, we recently assessed an experimental advanced cell therapy (ACT) approach using umbilical cord mesenchymal stem cells (UC-MSCs) in combination with radiotherapy (RT), which has shown promising positive effects, such as reduction of tumor growth and metastatic dissemination. Research studies suggested a synergistic effect of UC-MSCs and RT in a tumor xenograft model in NOD/SCID-gamma mice using different human cancer cell lines. Requirements for clinical translation for colorectal cancer treatment were evaluated by AIAT. While researchers' published data were mainly focused on efficacy, we pointed out the need of complementary experiments addressing toxicity and safety, as well as biodistribution. This collaboration helped to complete the preclinical dataset in compliance with stringent Stem Cell Therapy Medicinal Product (SCTMP) EMA specifications. As a result, a scientific advice request was made and this work got a preliminary accordance of the National Regulatory Agency (AEMPS).